⛔ FDA Black Box Warning
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs [see Indications and Usage ( 1.2 ), Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning. Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion ( 5.1 ) ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis ( 1.2 , 2.4 , 5.1 ) Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs ( 2.4 , 5.1 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no data on the use of ANTHIM in pregnant women to inform on drug-associated risk. There are adverse effects on maternal and fetal outcomes associated with anthrax in pregnancy (see Clinical Considerations ). In pregnant rabbits, intravenous administration of obiltoxaximab during organogenesis was not associated with adverse developmental outcomes at up to 0.62 times the human systemic exposure at the maximum recommended adult dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment. Data Animal Data: A study was conducted in pregnant, healthy, New Zealand White rabbits administered intravenous obiltoxaximab at dose levels of 16 or 32 mg/kg during organogenesis on Gestation Days 6, 10, 13 and 17. No maternal toxicity or adverse developmental outcomes were observed at the highest tested dose, 32 mg/kg. In those rabbits, mean maternal maximum plasma concentration (C max = 1180 mcg/mL) and mean maternal AUC inf (3220 mcg•day/mL) were approximately 3 times and 0.62 times the respective values for C max and AUC reported in clinical trial subjects at the maximum recommended adult dose of 16 mg/kg.